Influence of a randomized clinical trial on practice by participating investigators: lessons from the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT). CAVEAT I and II Investigators.
OBJECTIVE
We sought to determine whether the results of the first Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I) influenced subsequent practice patterns among the investigators.


BACKGROUND
CAVEAT-I demonstrated that directional coronary atherectomy (DCA) resulted in higher rates of early complications at a higher cost and with no clinical benefit. We sought to determine whether these results influenced subsequent use of procedures among CAVEAT-I investigators.


METHODS
We compared the results of a week-long registry of all coronary interventions performed at 35 CAVEAT-I sites in 1994 with those of a similar registry obtained in 1992 before the trial, the results of which were published in 1993. For control purposes, the use of procedures was studied at 24 additional sites to provide insight into practice at hospitals not participating in the trial. A total of 1,465 interventions were analyzed.


RESULTS
Ninety-four percent of CAVEAT-I sites responded. Utilization rates differed between CAVEAT-I and CAVEAT-I follow-up (p < 0.001). Balloon angioplasty decreased from 83.8% to 68.5%, DCA increased slightly from 10.7% to 14.1%, and the use of other devices increased from 5.4% to 17.5%. Stand-alone balloon use was more prevalent at nonparticipating control sites than at sites that took part in CAVEAT-I (p < 0.001).


CONCLUSIONS
Paradoxically, despite the negative findings of CAVEAT-I, there was a noteworthy trend toward an increase in the use of DCA and other devices at CAVEAT-I sites. Our findings suggest that among investigators in the trial, there may have been a lack of influence of trial data on clinical practice patterns 1 year after publication of the results. Ethics of protocol: Both CAVEAT I and II were approved by the Institutional Review Board at each study site.
Omoigui
N A
NA
Department of Medicine, University of South Carolina, Columbia 29203, USA. nowa@richmed.medpark.sc.edu
Silver
M J
MJ
Rybicki
L A
LA
Rosenthal
M
M
Berdan
L G
LG
Pieper
K
K
King
S V
SV
Califf
R M
RM
Topol
E J
EJ
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D015906:Angioplasty, Balloon, Coronary / Q000706:statistics & numerical data; D017225:Atherectomy, Coronary / Q000009:adverse effects / Q000191:economics / Q000706:statistics & numerical data; D016009:Chi-Square Distribution; D003327:Coronary Disease / Q000601:surgery / Q000628:therapy; D003331:Coronary Vessels / Q000473:pathology / Q000601:surgery; D003365:Costs and Cost Analysis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010818:Practice Patterns, Physicians'; D015995:Prevalence; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D019233:Retreatment; D012501:Saphenous Vein / Q000637:transplantation; D012737:Sex Factors; D016896:Treatment Outcome